ApexCut Blade with Automated EM Tracking (6 models)— 510(k) K262235
Substantially EquivalentMedtronic Xomed, Inc.
FDA 510(k) clearance K262235 for ApexCut Blade with Automated EM Tracking (6 models), Substantially Equivalent on 2026-09-04. Applicant: Medtronic Xomed, Inc.. Device class: 2.
Summary
Medtronic Xomed's clearance covers six ApexCut Blade with Automated EM Tracking models, numbered 187BL4012EM, 187BL4040EM, 187BL4060EM, 187BL2975EM, 187BL3590EM, and 187BL4000LEM. Product code PGW is ear, nose, and throat stereotaxic instruments. The record doesn't say how the models differ.
Class II, 21 CFR 882.4560. The Ear, Nose, and Throat review panel handled it as a Traditional 510(k), though the record lists Neurology as the classification panel.
Medtronic Xomed filed from Jacksonville, Florida. Review took 65 calendar days (July 1 to September 4, 2026).
Clearance details
- Device name as filed
- ApexCut Blade with Automated EM Tracking (187BL4012EM);ApexCut Blade with Automated EM Tracking (187BL4040EM);ApexCut Blade with Automated EM Tracking (187BL4060EM);ApexCut Blade with Automated EM Tracking (187BL2975EM);ApexCut Blade with Automated EM Tracking (187BL3590EM);ApexCut Blade with Automated EM Tracking (187BL4000LEM)
- Applicant
- Medtronic Xomed, Inc.
- Product code
- Product code PGW
- Device class
- Class 2
- Regulation
- 21 CFR 882.4560
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jacksonville, FL, US
Recent devices under product code PGW
view allMore clearances from Medtronic Xomed, Inc.
view all- K251672 — NIM Essence EMG Endotracheal Tube (5 models)
- K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotracheal Tube
- K231580 — NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)
- K213246 — NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
- K210841 — NuVent Eustachian Tube Dilation Balloon
Adverse events under product code PGW
product code PGW- Malfunction
- 1,199
- Total
- 1,199
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.